Exact Sciences is committed to supporting patient access to the Oncotype DX Breast DCIS Score test to help your patients make informed decisions about their treatment.
Financial Responsibility Information
financial responsibility for Oncotype DX Breast DCIS Score when Medicare fee for service (FFS) coverage criteria are met
Medicare Advantage, which is provided by commercial insurance companies, may have different financial responsibility compared to Medicare FFS.
Exact Sciences strongly encourages patients to contact their insurer when they have questions about their benefits. Regardless of network status, all commercial insurance coverage is governed by an insurer’s medical policy and patient benefit type.
If your patient’s out-of-pocket amount is $500 or more as determined by the patient’s insurance, they will receive a call from our Exact Sciences’ billing team to discuss payment options. We will also submit secondary or supplemental insurance claims on your patient’s behalf if the necessary information was submitted with the order. If your patient receives a bill and is not sure if a claim was submitted to their secondary or supplemental insurance, please have your patient contact us.
FFS Medicare and Medicare Advantage plans cover the Oncotype DX Breast DCIS Score test for eligible patients with ductal carcinoma in situ (DCIS). Exact Sciences† is an in-network provider with many health plans, including Aetna, Anthem, Cigna, Humana and UnitedHealthcare. Since insurance coverage can vary across the country, it’s a good idea to check with your patient’s carrier or contact our Customer Service team to confirm coverage. The Oncotype DX Breast DCIS Score test is reported on claims with the unique proprietary laboratory analysis (PLA) code 0045U.
Partnering with You & Your Patients
Genomic Access Program (GAP)
Exact Sciences believes that everyone should have access to the information they need to make confident, informed decisions about their cancer treatments. To advance this mission, we created GAP to help patients navigate and understand the insurance and billing process for the Oncotype tests. The GAP team can:
- Work with clinicians to get prior authorization from insurance companies (if required).
- Bill insurance companies directly when possible.
- Process the claim once the test is complete.
- With your patient’s consent, assist in the appeal process if a claim is denied.
- Contact insurance companies on patients’ behalf.
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For faster results, complete your requisition form online on the Physician Portal as insurance can be verified and most required forms can be pre-filled and completed online. If you do not have an online ordering account, sign up today.
Exact Sciences offers financial assistance programs for eligible patients with financial hardship. These programs are based on financial eligibility.
- Financial assistance is available for eligible patients who are uninsured and may be available for insured patients unable to pay the out-of-pocket amount determined by their insurance.
- Eligibility is based on Federal poverty guidelines, and we proactively contact all uninsured patients to determine eligibility for financial assistance. Payment plans may also be available.
- Financial assistance is not available if the patient has insurance coverage but elects to be billed directly instead of billing insurance.
Patients may also contact us before the test is ordered or during the testing process to review available payment terms or to be pre-screened for financial assistance. To learn more, contact our Customer Service by phone at ( 866-ONCOTYPE866-662-6897, option 2) or message us for more information.
The Medicare 14-Day Rule
FFS Medicare has specific date of service reporting requirements for laboratory tests, and the technical component of physician pathology services, ordered for Medicare patients (commonly known as the “14-Day Rule”). The 14-Day Rule determines whether the laboratory performing the test bills Medicare directly or bills the hospital where the specimen was collected.
In general, Medicare requires that laboratories bill the hospital when the test is ordered less than 14 days following a patient’s inpatient or outpatient hospital stay (when the specimen was collected). However, as of January 1, 2018, the 14-day rule does not apply to molecular pathology tests when the specimen is collected from a hospital outpatient, regardless of order date.
We process test orders as they are received from providers. Clinical judgment should be the determining factor for test ordering.
See Medicare Specific Coverage Criteria
Local Coverage Determination (LCD): MolDX: Oncotype DX Breast DCIS Score Assay (Genomic Health) (L36941)
See the full LCD
The Oncotype DX Breast DCIS Score assay is covered only when the following clinical conditions are met:
- Pathology (excisional or core biopsy) reveals ductal carcinoma in situ of the BREAST (no pathological evidence of invasive disease), and
- FFPE specimen with at least 0.5 mm of DCIS length, and
- Patient is a candidate for and is considering BREAST conserving surgery alone as well as BREAST conserving surgery combined with adjuvant radiation therapy, and
- Test result will be used to determine treatment choice between surgery alone vs. surgery with radiation therapy, and
- Patient has not received and is not planning on receiving a mastectomy.